Brazilian medical device market regulators have eased requirements for making changes to lower-risk or cadastro registrations for medical devices and IVDs.

According to a Technical Note (link in Portuguese) issued by ANVISA, Brazilian market participants seeking to make multiple modifications to their cadastro registrations may now submit all proposed changes to regulators using a single application form; ANVISA will also no longer charge a review fee for modification applications for cadastro devices, the Technical Note states.

Furthermore, the Technical Note makes no mention of modifications to higher-risk registro registrations, so all fees and application processes pertaining to these devices remain in place at ANVISA.

At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.